Tuberculosis vaccine

Tuberculosis (TB) caused an estimated 1.25 million deaths in 2023, with the overwhelming majority of the disease burden falling on low- and middle-income countries (LMICs). TB control continues to rely heavily on diagnosis and lengthy antibiotic treatment regimens, while rising drug resistance poses an increasing challenge.

In reponse to this need, Statens Serum Institut (SSI), in collaboration with EuBiologics, is developing H107e/CAF®10b, a novel subunit TB vaccine candidate designed to protect adolescents and adults, including people living with HIV. Following a completed Phase Ia trial and an ongoing Phase Ib trial in South Africa showing a favorable safety profile and promising immunogenicity, this grant supports optimization of the GMP manufacturing process and technology transfer to EuBiologics. This includes production of GMP drug substance and drug product batches of the improved H107eV variant, laying the groundwork for late-stage clinical trials and the development of an affordable TB vaccine that can be made broadly accessible in LMICs.